Integrated surgical staple retainer for a full thickness resectioning device

ABSTRACT

An integrated surgical staple retainer for use in the full thickness resectioning device is described. The integrated surgical staple retainer comprises a calibrating portion, a retaining portion, and a grasping portion. The calibrating portion defines a circular opening which has a diameter substantially equal to a diameter of a working channel of the full thickness resectioning device. The retaining portion has a lower surface adapted to limit movement of the surgical staples in the fill thickness resectioning device and is adjacent to the calibrating portion of the integrated surgical staple retainer.

RELATED APPLICATIONS

[0001] The present application is a continuation in part of applicationSer. No. 09/694,894, filed Oct. 25, 2000 which is a continuation ofapplication Ser. No. 09/316,674, filed May 21, 1999, which in turn is adivision of application Ser. No. 09/100,393, filed Jun. 19, 1998, titledMethod and Device for Full Thickness Resectioning of an Organ.

FIELD OF INVENTION

[0002] The present invention relates to full thickness resection devices(FTRD's) for performing localized resections of lesions in tubularorgans, particularly the colon.

BACKGROUND INFORMATION

[0003] A resection procedure involves excising a portion of an organ,approximating the surrounding tissue together to close up the holecreated by the excision, and removing the excess tissue. Variousconventional devices and procedures are available for resectioninglesions in tubular organs.

[0004] For example, several known resection devices and proceduresrequires at least one incision in an area near the portion of the organto be excised for access to the lesion or treatment site (because, forexample, the resectioning device may lack steering and/or viewingcapabilities). Thus, the incision is required to allow the physician toaccess the organ section to be excised and guide the device to thatsection. Alternatively, when the organ section to be excised is beyondthe reach of the surgical device, or the surgical device is not flexibleenough to wind through the organ to the site to be excised, an incisionwill be required to position the device for the procedure. Of course,these incisions are painful and may involve a partial or entire loss ofmobility while recuperating from the incision, in addition to recoveringfrom the tubular resectioning procedure itself. In addition, the timerequired to recover from such a procedure is often longer than forprocedures which do not require incisions.

[0005] One type of conventional resection procedure utilizes a circularstapling instrument in which a tubular section of a tubular organ isexcised, resulting in the tubular organ being separated into a firstsegment and a second segment. The end sections of the first and secondsegments are then individually tied in a purse string fashion,approximated, stapled, and the “purse stringed” end sections are thencut off. In this full circle resectioning procedure, at least oneseparate invasive incision must be made near the section to be excisedin order to cut and individually tie the separate end sections of theorgan. Also, a separate incision is necessary to place one part of theresectioning device in the first segment and a corresponding second partof the device in the second segment so that the device can then bringthe first and second segments together to re-attach the organ sectionsback together. A first of these separate parts may generally include astaple firing mechanism while the second part includes an anvil forforming the staples. Thus, this type of resectioning procedure involvesthe drawbacks mentioned above in regard to procedures requiring invasiveincisions. In addition, the separation of the organ into two segmentscreates the risk of spillage of non-sterile bowel contents into thesterile body cavity, which can cause severe infection and possiblydeath.

[0006] An alternative resectioning device includes a stapling andcutting assembly on a shaft which can be bent or formed into a desiredshape and then inserted into a patient's body cavity. Once the shaft hasbeen bent into the desired shape, the rigidity of the shaft ensures thatshape is maintained throughout the operation. This arrangement limitsthe effective operating range of the device as the bending of the shaftinto the desired shape before insertion and the rigidity of the shaftonce bent require the physician to ascertain the location of the organsection to be removed before insertion, and to deform the shaftaccordingly. Furthermore, the rigidity of the shaft makes it difficultto reach remote areas in the organ—particularly those areas which mustbe reached by a winding and/or circuitous route (e.g., sigmoid colon).Thus, an incision may be required near the organ section to be excisedin order to position the device at the organ section to be excised.

[0007] In addition, conventional stapling devices include stapleretainers which serve only a limited function. Conventional stapleretainers which accompany stapling devices are generally intended toonly secure the staples during shipment. This can be problematic as thesurgeon has to use a separate instrument to gauge the diameter of anendoscope to ensure the endoscope is not too large to fit through theworking channel of the resectioning device. The separate endoscope gaugecould easily be lost during unpacking of the resectioning device sinceit is not attached to the device. In addition, there is an additionalcost in manufacturing a separate endoscope gauge. There is thus a needfor an integrated staple retainer which is capable of securing staplesand gauging an endoscope and which can be placed within a resectioningdevice.

[0008] The full thickness resectioning device presents a uniquechallenge with the need to introduce a flexible endoscope through aninternal lumen of the device. Flexible endoscopes are manufactured andrepaired by numerous entities with little regard for standardization ofmaximum outer specification. The cost of repairing a damaged endoscopeis high and the attempted forced introduction of a flexible endoscopeinto the full thickness resectioning device will damage the endoscope.There is, therefore, a strong need for a means of insuring that onlyendoscopes of an appropriate diameter are utilized.

SUMMARY OF THE INVENTION

[0009] The present invention is directed to a full-thickness resectionsystem comprising a flexible endoscope and a stapling mechanism, whereinthe endoscope is slidably received through at least a portion of thestapling mechanism. The stapling mechanism includes an anvil and astapling head mounted to the anvil so that the anvil and the staplinghead are moveable with respect to one another between a tissue receivingposition and a stapling position and wherein a gap formed between thestapling head and the anvil is larger in the tissue receiving positionthan it is in the stapling position. A position adjusting mechanism isprovided for moving the anvil and the stapling head between the tissuereceiving and stapling positions and a staple firing mechanismsequentially fires a plurality of staples from the stapling head acrossthe gap against the anvil and through any tissue received in the gap anda knife cuts a portion of tissue received within the gap. A control unitwhich remains outside the body is coupled to the stapling mechanism forcontrolling operation of the position adjusting mechanism and the staplefiring mechanism. An integrated surgical staple retainer and endoscopediameter gauge is provided to retain the staples in place duringshipping of the FTRD, and to allow the user to conveniently check thatthe endoscope will fit through the FTRD.

[0010] In an exemplary embodiment, the current invention is directed toan integrated surgical staple retainer for use in a full thicknessresectioning device. The integrated surgical staple retainer comprises acalibrating portion and a retaining portion. The calibrating portiondefines a circular opening which has a diameter substantially equal to adiameter of a working channel of the full thickness resectioning device.The retaining portion has a surface adapted to limit movement of thesurgical staples in the full thickness resectioning device. Theretaining portion is adjacent to the calibrating portion of theintegrated surgical staple retainer.

[0011] A different aspect of the current invention is directed to amethod of gauging the outermost diameter of an endoscope for use in anintegrated surgical staple retainer. The calibrating portion is removedfrom the FTRD and is slid over the outermost diameter of the endoscope.

[0012] Another aspect of the current invention is directed to a methodof retaining staples in a full thickness resectioning device using anintegrated surgical staple retainer. The retaining portion is placedbetween a proximal housing and an anvil member of a full thicknessresectioning device. The distance between these two sections of theresectioning device is then minimized so that the integrated surgicalstaple retainer remains in position relative to the resectioning device.

BRIEF DESCRIPTION OF THE DRAWINGS

[0013]FIG. 1 shows a device according to a first embodiment of thepresent invention;

[0014]FIG. 2 shows the device of FIG. 1 mounted on a conventionalendoscope;

[0015]FIG. 3 shows the device of FIG. 1 with a grasper mechanismextending therefrom;

[0016]FIG. 4 shows a cutaway of the device of FIG. 1 showing a drivemechanism thereof;

[0017]FIG. 5 shows a cutaway of the device of FIG. 1 showing anactuating mechanism;

[0018]FIG. 6 shows a detailed view of the wedge used in the actuatingmechanism of FIG. 5;

[0019]FIG. 7 shows a cut-away view of a working head assembly of thedevice of FIG. 1;

[0020]FIG. 8 shows a rear cover plate of the working head assembly ofFIG. 7;

[0021]FIG. 9a shows a mechanism for restricting motion of a drive shaftof the device of FIG. 1;

[0022]FIG. 9b shows a first coupling arrangement for a drive cable and adrive shaft in the 30 device of FIG. 1;

[0023]FIG. 9c shows a second coupling arrangement for the drive cableand the drive shaft in the device of FIG. 1;

[0024]FIG. 9d shows a perspective cut-away view of a sheath of thedevice of FIG. 1;

[0025]FIG. 10a shows a perspective view of an alternative constructionof the wedge of FIG. 6;

[0026]FIG. 10b shows a cut-away view of the wedge of FIG. 10a;

[0027]FIG. 10c shows a blade portion corresponding to the wedge of FIG.10a;

[0028]FIG. 11 shows a device according to a second embodiment of thepresent invention;

[0029]FIG. 12 shows a device according to a third embodiment of thepresent invention;

[0030]FIG. 13 shows a device according to a fourth embodiment of thepresent invention;

[0031]FIG. 14a shows a device according to a fifth embodiment of thepresent invention;

[0032]FIG. 14b shows a detailed cut-away view of the device of FIG. 14aand a conventional endoscope;

[0033]FIG. 15 shows a control handle for use with the devices accordingto the present invention;

[0034]FIG. 16 shows a blade housing arrangement for use with a deviceaccording to the present invention;

[0035]FIG. 17 shows a first arrangement of a blade shield for use with adevice according to the present invention;

[0036]FIG. 18 shows a second arrangement of the blade shield for usewith a device according to the present invention;

[0037]FIG. 19a shows a third arrangement of the blade shield for usewith a device according to the present invention;

[0038]FIG. 19b shows a tissue blocker of the blade shield of FIG. 19a;

[0039]FIG. 19c shows a distal end of a proximal housing of the device ofFIG. 19a; and

[0040]FIG. 20 shows a device according to a sixth embodiment of thepresent invention.

[0041]FIG. 21 shows a device according to a seventh embodiment of thepresent invention.

[0042]FIG. 22 shows a first perspective view of the device of FIG. 21.

[0043]FIG. 23 shows a second perspective view of the device of FIG. 21.

[0044]FIG. 23a shows a third perspective view of the device of FIG. 21.

[0045]FIG. 24 shows a side cut-away view of the device of FIG. 21.

[0046]FIG. 25 shows a fourth perspective view of the device of FIG. 21.

[0047]FIG. 26 shows a cut-away view of an exemplary stapler member ofthe device of FIG. 1.

[0048]FIG. 27 shows a perspective view of an integrated surgical stapleretainer according to a first embodiment of the present invention.

[0049]FIG. 28 shows a perspective view of an integrated surgical stapleretainer according to a second embodiment of the present invention.

[0050]FIG. 29 shows a perspective view of an integrated surgical stapleretainer in relation to a full thickness resectioning device accordingto an embodiment of the present invention.

[0051]FIG. 30 shows a perspective view of an integrated surgical stapleretainer placed within a full thickness resectioning device according toan embodiment of the present invention.

[0052]FIG. 31 shows a perspective view of a calibrating portion of anintegrated surgical staple retainer gauging the outermost diameter of anendoscope according to an embodiment of the present invention.

DETAILED DESCRIPTION

[0053] As shown in FIGS. 1 and 2, an apparatus according to a firstembodiment of the present invention comprises a working head assembly 2which may preferably be connected to a distal end 4 a of a sheath 4. Theproximal end 4 b of the sheath 4 may preferably be connected to acontrol handle 6.

[0054] In operation, the entire apparatus is mounted onto an endoscope 8by passing the endoscope 8 through the control handle 6, the sheath 4,and the working head assembly 2, as shown in FIG. 2. The endoscope 8 isthen inserted into a body orifice to locate a lesion in the tubularorgan under visual observation (usually while insufflating the organ).Once the lesion has been located, the working head assembly 2 and thesheath 4 are slidably advanced along the endoscope 8 into the tubularorgan until the working head assembly 2 is in a desired positionadjacent to the lesion. Those skilled in the art will understand that inan alternative embodiment, the working head assembly 2 may also bedetachably coupled to a distal end of the endoscope 8, and the entirearrangement may then be inserted into the body orifice under visualobservation.

[0055] As shown in FIG. 1, the working head assembly 2 comprises ananvil member 10 coupled to a distal end 12 a of a proximal housing 12.The anvil member 10 has a substantially crescent-shaped cross-section(i.e., the outer edge 18 of the anvil member 10 substantially forms aportion of a first circle with a second smaller circular cut-out 13formed within the first circle) with a proximal face 14 and a smallerdistal face 16. The cut-out 13 of the anvil member 10 is included toallow the endoscope 8 to be slid through the entire working headassembly 2 so that the endoscope 8 may be advanced into the body passageallowing the working head assembly 2 to later be advanced into the bodyto the lesion. In addition, the cut-out 13 also provides forward visionvia the endoscope 8. Thus, any shape of the cut-out 13 may be selectedwhich is large enough to accommodate the endoscope 8, with a largercut-out providing a larger field of vision. An outer surface 18 of theanvil member 10 extends substantially parallel to a central axis of theworking head assembly 2 while the proximal and distal faces 14, 18 ofthe anvil member 10 extend in planes substantially perpendicular to thecentral axis. The outer surface 18 is joined to the distal face 16 by atapered portion 5.

[0056] As shown in FIG. 3, the proximal face 14 of the anvil member 10includes a first cavity 37 and a rim 41 encircling the first cavity 37.A plurality of staple forming grooves 19 are arranged in two offset rowson the rim 41 of the anvil member 10 and a circular guiding slit 21extends radially within the rows of grooves 19. The rim 41 protrudesfrom the remainder of the proximal face 14 so that a shallow cavity isformed on the proximal face 14.

[0057] The anvil member 10 is coupled to the proximal housing 12 bymeans of two mounting shafts 20 a and 20 b, which may preferably besubstantially cylindrical. Each mounting shaft 20 a, 20 b is coupled tothe proximal face 14 of the anvil member 10 on a respective one of twohorns 22 a, 22 b formed by the crescent-shaped anvil member 10. Althoughthe anvil member 10 is shown fixedly coupled to the mounting shafts 20a, 20 b, those skilled in the art will understand that the anvil member10 may also be pivotally coupled to the mounting shafts 20 a, 20 b inorder to provide a greater field of vision through the endoscope 8 asshown in FIG. 3a. In this pivoted-type arrangement, the anvil member 10is angled in a first configuration so that the horns 22 a, 22 b arecloser to the distal end 12 a of the proximal housing than the rest ofthe anvil member 10. Then, as the anvil member 10 is drawn towards thedistal end 12 a of the proximal housing 12, the anvil member 10 would bepressed against the distal end 12 a beginning with the horns 22 a, 22 b,which would cause the anvil member 10 to pivot until the proximal face14 of the anvil member 10 is parallel to the distal end 12 a.

[0058] As shown in FIG. 1, the mounting shafts 20 a, 20 b are slidablyreceived in mounting holes 26 a, 26 b, which have a size and shapesubstantially corresponding to the size and shape of the mounting shafts20 a, 20 b and which run axially through the proximal housing 12. Themounting shafts 20 a, 20 b are preferably movable axially proximally anddistally within the mounting holes 26 a, 26 b between a proximal mostposition in which a tissue gripping gap of a first predetermined widthis formed between the rim 41 and the distal end 12 a of the proximalhousing 12, and a distal most position in which a tissue receiving gapof a larger second predetermined width is formed between the rim 41 andthe distal end 12 a of the proximal housing 12. The second predeterminedwidth should preferably be more than twice the thickness of a wall ofthe organ being resectioned so that a section of the tubular organ maybe pulled into a resectioning position between the anvil member 10 andthe proximal housing 12.

[0059] As shown in FIG. 4, the proximal end of at least one of themounting shafts 20 a and 20 b is coupled to a drive mechanism 102provided within the proximal housing 12. In a preferred embodiment, thedrive mechanism 102 is composed of a yoke 103 and a drive shaft 105. Theyoke 103 is preferably slidably received within the proximal housing 12for longitudinal movement along the axis of the proximal housing 12 sothat, when the anvil member 10 is in the proximal most position, theyoke 103 is in a corresponding proximal most position and, when theanvil member is in the distal most position, the yoke 103 is in acorresponding distal most position.

[0060] The yoke 103 may preferably be substantially semicircular with asubstantially rectangular cross section. Although the semicircle formedby the yoke 103 in FIG. 4 forms substantially a quarter arc of a circle,the yoke 103 may form a larger semicircle based upon the interioraccommodations of the proximal housing 12 and the position of themounting shafts 20 a, 20 b. The mounting shaft 20 a may preferably becoupled to the yoke 103 at a first end 103 a of the yoke 103, and themounting shaft 20 b may be coupled at a second end 103 b of the yoke103. A shaft hole 107, having a diameter substantially corresponding toa diameter of a complementarily threaded distal end 105 a of the driveshaft 105, extends through the yoke 103 at a point substantially midwaybetween the first end 103 a and second end 103 b. Thus, when the driveshaft 105 is rotated, the threaded distal end 105 a engages the shafthole 107 to move the yoke 103 proximally or distally (in dependence uponthe direction of rotation of the drive shaft 105).

[0061] The distal end 105 a of the drive shaft 105 should preferably bethreaded over a first section 105 t substantially corresponding inlength to at least the distance between the proximal and distal mostyoke positions, while a remainder portion 105 r may have no threadsthereon. The drive shaft 105 may have an increased cross-section in theareas immediately adjacent to the threaded first section 105 t(proximally and/or distally of section 105 t), thereby limiting themovement of the yoke 103 to the first section 105 t. Those skilled inthe art will understand that the drive shaft 105 is preferably rotatablymounted within the proximal housing 12 so that it may only rotated andmay not move relative to the proximal housing 12. The drive shaft 105preferably extends to a proximal end 105 b which is coupled to a drivecable 100 which extends to the control handle 6 through the sheath 4.The drive cable 100 may preferably run axially along the peripheralinterior of the sheath 4. Those skilled in the art will understand thatthe sheath 4 is preferably torsionally stiff to resist the torque forcesfrom the drive cables rotating therein. However, the sheath 4 islongitudinally flexible to so that it may be slidably advanced along theendoscope 8, while minimizing interference with the operation of theendoscope 8 and trauma to surrounding tissue. The sheath 4 is preferablyconstructed similar to known endoscope insertion tubes, which areflexible yet allow the transfer of forces to swivel the distal end ofthe endoscope 8 in multiple directions and the torqueable rotation ofthe endoscope.

[0062] FIGS. 7-10 show a cutaway view of the working head assembly 2 inFIG. 1, in which the respective movements of the drive shaft 105 and theyoke 103 are restricted in the manner described above. As shown in FIG.8, a pearshaped rear cover plate 460 may preferably be connected to theproximal end 12 b of the proximal housing 12. A first shaft hole 462having a cross-sectional size substantially corresponding to thecross-sectional size of the drive shaft 105 is provided in a lowerportion of the rear cover plate 460 for receiving the drive shaft 105therethrough. Thus, the yoke 103 is restricted to only longitudinalmovement in this arrangement because, the distal side of the yoke 103 iscoupled to the mounting shafts 20 a, 20 b which are disposed in themounting holes 26 a, 26 b, and the proximal side of the yoke 103 iscoupled to the drive shaft 105 which is disposed in the first shaft hole462.

[0063] As shown in FIG. 9a, the movement of the drive shaft 105 may berestricted to only rotation movement about its axis by two washer-typedevices 470 fixedly attached to the drive shaft 105 on either side ofthe rear cover plate 460. A similar result may be achieved by providingthe drive shaft 105 with a larger cross-sectional size on either side ofthe rear cover plate 460 in relation to the portion of the drive shaft105 within the rear cover plate 460. Alternatively, the cross section ofa bulging portion 476 of the drive shaft 105 located substantially inthe center of the rear cover plate 460 may be larger than the portionsof the drive shaft 105 immediately adjacent to the bulging portion 476.The first shaft hole 462 may then have a center portion 474 with alarger cross-section than the rest of the first shaft hole 462 toaccommodate the bulging portion 476 of the drive shaft 105.

[0064]FIG. 9b shows a coupling arrangement between the drive cable 100and the drive shaft 105 in which a proximal end 105 a of the shaft mayhave a D-shaped hole 105h extending therethrough. A distal end 102 b ofthe drive cable 100 has a D-shape corresponding to the shape of the hole105h so that the distal end 102 b of the drive cable may be receivedwithin the hole 105 h in the drive shaft 105. FIG. 9c shows analternative coupling arrangement for coupling the drive cable 100 to thedrive shaft 105 in which the hole 105 h in the proximal end 105 a of thedrive shaft 105 a and the distal end 102 b of the drive cable 100 havecorresponding squarish shapes. The single edge provided by the D-shapesin FIG. 9b and the four edges provided by the squarish shapes in FIG. 9callow the drive cable 100 to transfer a rotational force to the driveshaft 105 with minimal slippage.

[0065] In operation, the user advances the endoscope 8, with the workinghead assembly 2 received there around, to a portion of tissue to beresectioned until the working head assembly 2 is in a desired positionadjacent to the tissue to be resectioned. The user may then apply aforce to the control handle 6 to rotate the drive cable 100 which inturn rotates the drive shaft 105 to advance the yoke 103 and the anvilmember 10 distally away from the distal end 12 a of the proximal housing12. As shown in FIG. 3 when the anvil member 10 has reached the distalmost position, a known grasping device 108 is advanced through thesheath 4 and through the working head assembly 2 to enter the gapbetween the anvil member 10 and the distal end 12 a via one of thegrasper holes 32 and 33. Although the device in FIG. 3 is shown using aduodenoscope as the endoscope 8, those skilled in the art willunderstand that other types of endoscopes may also be used, such as, forexample, gastroscope, colonoscope, etc.

[0066] As shown in FIG. 1, at least the distal end 12 a of the proximalhousing 12 preferably has a cross-section corresponding in size andshape to the proximal face 14 of the anvil member 10, including acut-out 29 substantially corresponding in size and shape to the cutout13 of anvil member 10. The cut-out 29 is provided to receive theendoscope 8 therein and allow the proximal housing 12 to be slidablyadvanced along the endoscope 8. Of course, those skilled in the art willunderstand that the shape of the outer surface of the working headassembly 2 may be selected in order to accommodate various desiredresectioning shapes, and the shape of the anvil member 10 may preferablybe selected to form a continuous surface when positioned adjacent to theproximal housing 12 to facilitate advancing the working head assembly tointo and removing it from, body passages. It is preferable that theworking head assembly have a maximum diameter at any point between 15 mmand 40 mm.

[0067] A tissue receiving cavity 30 is formed substantially centrally inthe distal end 12 a of the proximal housing 12 to facilitate the drawingof sections of tubular organs into the gap between the anvil member 10and the distal end 12 a. Those skilled in the art will understand thatthe depth of the cavity 30 may vary depending on the amount of tissue tobe pulled into the cavity 30 and the size of the proximal housing 12.Two grasper holes 32 and 33 extend axially, preferably slightlyoff-center from the longitudinal axis of the proximal housing 12. In apreferred embodiment, the grasper holes 32 and 33 may each preferablyreceive a grasping device 108 advanced from the control handle 6,through the sheath 4, and through a respective one of the grasped holes32 and 33.

[0068] In operation, either one or two grasping devices 108 may then beused to pull a section of the tubular organ between the anvil member 10and the distal end 12 a of the proximal housing 12 and into the cavity30. A third grasping device 108 may also be inserted through the workingchannel of the endoscope 8 to provide another means of positioning theorgan section between the anvil member 10 and the proximal housing 12.Of course, those skilled in the art will understand that any desiredinstrument may be advanced to the gap between the anvil member 10 andthe distal end 12 a through any of the grasped holes 32, 33 and theworking channel of the endoscope 8.

[0069] A plurality of staple slits 34 are preferably disposed in twooffset substantially circular rows extending along the periphery of thedistal end 12 a of the proximal housing 12. The staple slits 34 extendfrom an area adjacent to the mounting shaft 26 a to an area adjacent tothe other mounting shaft 26 b. The plurality of staple slits 34 maypreferably be arranged so that when the anvil member 10 is in theproximal most position, each of the staple slits 34 is aligned with acorresponding one of the staple-forming grooves 19.

[0070] When the device is configured for operation, a plurality ofstaples is received within the working head assembly 2 with each of thestaples being aligned with a respective one of the staple slits 34. Thestaples are then sequentially fired from the respective staple slits 34by an actuating mechanism 104 (shown in FIG. 5) disposed in the proximalhousing 12.

[0071] A substantially circular blade slit 36 extends substantiallyradially within the staple slits 34 so that, when the anvil is in theproximal most position, the blade slit 36 is aligned with the guidingslit 21 on the anvil member. As shown more clearly in FIG. 12,extensions 84 a and 84 b of the blade slit 36 extend into blade housings74 a and 74 b, respectively, which project distally from the distal end12 a of proximal housing 12. The blade housings 74 a and 74 b arepreferably situated so that when the anvil member 10 is in its proximalMost position, the blade housings 74 a and 74 b contact portions 43 aand 43 b of the rim 41 of the anvil member 10. The extension of theblade housings 74 a and 74 b from the proximal housing 12 is preferablyselected BO that when the blade housing devices 74 a and 74 b engage theremainder portions 43 a and 43 b of the rim 41 (thereby stopping aproximal movement of the anvil member 10 and defining the proximal mostposition thereof), a gap is formed between the anvil member 10 and thedistal end 12 a of a length sufficient to allow the anvil member 10 tosecurely hold a portion of the organ against the proximal housing 12without crushing and damaging the portion of the organ.

[0072] When positioned at one end of the blade slit 36 (i.e., in one ofthe extensions 84 a and 84 b), a cutting blade 202 is preferablycompletely enclosed within the respective one of the blade housingdevices 74 a and 74 b and the guiding slit 21, so that the cutting blade202 does not cut any tissue until the physician intentionally operatesthe blade 202. When the physician operates the blade 202, the blade 202is driven from its initial position received within one of theextensions 84 a and 84 b around the blade slit 36 with its cutting edgefacing a direction of movement, until the blade 202 is received into theother one of the extensions 84 a and 84 b. Thus, after a cuttingoperation has been performed, the blade 202 is once again prevented frominadvertently injuring the patient.

[0073]FIG. 6 shows a wedge 402, a first portion 402 a of which isnon-rotatably coupled to an actuating shaft 400 so that rotation of theshaft 400 the wedge 402 rotates, preferably about the longitudinal axisof the working head assembly 2. The wedge 402 includes a blade handle408 which extends from a first portion 408 a coupled to the wedge 402 toa second portion 408 b which is coupled to the blade 202 so that, whenthe wedge 402 is rotated, the blade 202 is rotated through the bladeslit 36. The wedge 402 has a substantially bell-like cross-section whenviewed axially, with a second portion 402 b extending radially outwardfrom the first portion 402 a and, consequently, from the longitudinalaxis of the shaft 400 which preferably coincides with the longitudinalaxis of the working head assembly 2. A notch of varying depth is cut outof a radially outer portion of the second portion 402 b to form a camsurface 412 thereon. A first ramp section 412 a ramps up from a leadingface 402 d of the wedge 402 to adjoin a second ramp section 412 b thatramps down to adjoin a rear face 402 e of the wedge 402. The wedge 402is preferably arranged in the proximal housing 12 so that the camsurface 412 is substantially aligned with the staple slits 34.

[0074] A staple driver 472 extends substantially longitudinally,proximally from each of the staple slits 34 having toward the plane inwhich the wedge 402 rotates and each staple driver 472 is slidablyreceived within the working head assembly 2 for motion between a distalmost, staple driving position and a proximal most inoperative position.In the inoperative position, an upper end of each of the staple drivers472 is completely received within the proximal housing 12, just proximalof a respective staple. The staple drivers 472 are preferablysubstantially rectangular in shape, although bottom edges 472 a thereofmay more preferably be rounded. The length of the staple drivers 472 ispreferably selected so that, in the inoperative position, the bottomsurfaces 472 a extend into the plane of rotation of the wedge betweenthe proximal and distal most extents of the first ramp portion 412 a.The bottom surfaces 472 a are, in the inoperative position, morepreferably substantially aligned with the distal most projection of theof the cam surface 412 at the leading face 402 d. Thus in operation, thewedge 402 is rotated by the actuating shaft 400 so that the first rampsection 412 a of the cam surface 412 successively drives each of thestaple drivers 472 into contact with a corresponding staple so that eachstaple driver 472 and its staple are driven distally through arespective one of the staple slits 34. This drives the staples acrossthe gap from the distal end 12 a into the anvil member 10, through anytissue held between the anvil member 10 and the proximal housing 12, andinto the corresponding staple forming grooves 19. Thus the section ofthe tissue gripped between the anvil member 10 and the proximal housing12 is stapled in a pattern substantially the same as that formed by thestaple slits 34 (i.e., substantially circular). At the same time, theblade 202 is rotated through the blade slit 36 to cut the tissue whichhas just been stapled through the rotation of the wedge 402.

[0075] After each of the plurality of staples has been fired, the wedge402 may be driven in a reverse direction to reload a new plurality ofstaples. The wedge 402 may rotate in a direction opposite the staplefiring direction without getting caught on any of the staple drivers 472because the staple drivers are pushed out of the way by the second rampsection 412 b of the cam surface 412.

[0076] In operation, the user applies a force to the control handle 6 torotate an actuating cable 450 about its longitudinal axis. Thisrotational force is transferred to the actuating shaft 400, which thenrotates the wedge 402 around the longitudinal axis of the actuatingcable 450. The first ramp section 412 a of the cam surface 412 of thewedge 402 then individually drives the staple drivers 472 distally asdescribed above to staple the tissue received between 15 the anvilmember 10 and the proximal housing 12 with the cutting blade 202 laggingbehind the firing of the stapling since the blade handle 408 is coupledto the rear face 402 e of the wedge.

[0077]FIG. 10a shows an alternative configuration of the wedge 402 ofFIG. 6 including a separate blade portion 420. The blade portion 420 ispreferably rotatably coupled to the distal end 400 a of the actuatingshaft 400 so that a rotation of the actuating shaft 400 about itslongitudinal axis does not cause a corresponding rotation of the bladeportion 420. As in FIG. 6, the wedge 202 of this apparatus isnon-rotatably coupled to the distal end 400 a of the shaft 400.

[0078] The blade handle 408 of this apparatus, which is coupled to aperipheral edge 420 e of the blade portion 420, extends to the cuttingportion of the blade 202. As described above, the cutting portion of theblade 202 extends past the distal end 12 a except when the blade 202 isreceived within one of the extensions 84 a and 84 b.

[0079] The wedge 402 substantially corresponds in shape and size to thewedge 402 of FIG. 6, except that the blade handle 408 is not coupledthereto. In addition, a locking shaft 402 h extends into a distalsurface 402 t located as shown in FIG. 10a so that when the bladeportion 420 and the wedge portion 410 are aligned, the locking shaft 402h and a locking dimple 414 (shown in FIG. 10c) on the bottom face 420 bof the blade portion 420 are substantially aligned. As shown in FIG.10b, a spring 416 is received within the locking shaft 402 h with aproximal end of the spring coupled to the proximal end of the lockingshaft 402 h. A locking ball 418 coupled to the distal end 416 b of thespring 416 is sized so that when a proximally directed force is appliedto the locking ball 418, the locking ball 418 may be slidably receivedwithin the locking shaft 402 h. In addition, when no distally directedforce is applied to the locking ball 418, the spring 416 preferablyextends so that approximately one half (or more) of the locking ball 418extends distally out of the locking shaft 402 h. Thus, when the wedge402 is rotated toward the blade portion 420, the locking ball 418 isreceived in a cut-out 425 formed on the proximal surface 420 b of theblade portion 420. As shown in FIG. 10c, the cut-out 425 slopes downwardto adjoin the locking dimple 424 so that when the locking ball 418 isreceived, the slope of the cut-out 425 gradually pushes the locking ball418 into the locking shaft 420 h. Then, when the wedge 402 moves intoalignment with the blade portion 420, the locking ball 418 extends outof the locking shaft 402 h and enters the locking dimple 414 to couplethe wedge 402 to the blade portion 420 so that a rotation of the wedge402 causes a corresponding rotation of the blade portion 420.

[0080] A radial length B₁ between the peripheral edge 420 e of the bladeportion 420 and the actuating shaft 400 may substantially correspond toa radial length W₁ between the wall 402 f of the wedge portion 410 andthe actuating shaft. This places the blade handle 408 in substantiallythe same position, relative to the cam surface 402 c of the wedgeportion 410, as in the previous embodiments. Of course, those skilled inthe art will understand that it is important that the blade 408 shouldextend substantially distally to the blade slit 36 so that rotation ofthe blade portion 420 will cause a corresponding rotation of the blade202 through the blade slit 36.

[0081] In operation, the wedge 402 is initially situated distally of oneof the blade housings, e.g., 74 a while the blade portion 420 issituated distally of the blade housing 74 b with the blade 202 receivedin the blade housing 74 b. When the lesion tissue has been drawn intoposition between the distal end 12 a and the anvil member 10, thephysician actuates the shaft 400 by applying a force at the controlhandle 6. This causes the wedge portion 410 to rotate distally of thestaple slits 34, to sequentially drive each of the staple drivers 472distally through the corresponding staple slit 34. When the wedge 402has rotated filly into alignment with the blade portion 420 and thelocking ball 418 is received into the locking dimple 414, the operatorthen operates the control handle 6 in the opposite direction to draw theblade 202 out of the blade housing 74 b to cut all of the tissueextending radially inward of the rows of staples. When the blade 202 isreceived in the other blade housing 74 a, the wall of the body passageis released and the lesion tissue remains within the gap between thedistal end 12 a and the anvil member 10 held by the grasping devices108. The lesion tissue may then be withdrawn from the body for analysis.This embodiment of the wedge 402 provides a safeguard in case thestapling process must be prematurely aborted due to, for example, a jamin one of the staple slits 34. Using this embodiment, the cuttingprocess is not begun until all of the staples have been fired. Thus, itis possible to reduce the risk of cutting an opening in an organ whichis not completely closed by the staples.

[0082] As shown in FIG. 5, the actuating mechanism 104 includes theactuating cable 450 which extends from a proximal end 450 a coupled tothe control handle 6 to a distal end 450 b coupled to the proximal end400 a of the actuating shaft 400. Those skilled in the art willunderstand that the wedge 402 should preferably be situated towards thedistal end 12 a of the proximal housing 12 so that the yoke 103 does notinterfere with rotation of the wedge 402 around the longitudinal axis ofthe actuating shaft 400 (discussed below) even when the yoke 103 is inits distal most position.

[0083] As shown in FIGS. 7-9 a, the rear cover plate 460 may preferablybe coupled to the proximal end 12 b of the proximal housing 12. Theproximal end 12 b of the proximal housing 12 is then connected to thesheath 4. The actuating shaft 400 may preferably extend through a secondshaft hole 464 formed in the rear cover plate 460 of the proximalhousing 12 and preferably abuts an interior portion of the cavity 30provided on the proximal housing 12. An endoscope hole 466 maypreferably be provided on a portion of the rear cover plate 460 radiallyseparated from the longitudinal axis of the working head assembly 2 toguide the endoscope 8 into the cut-out 29 of the proximal housing 12.The endoscope 8 may preferably be received into the endoscope hole 466from an endoscope lumen 40 provided within the sheath 4 which ispreferably disposed along a periphery of the sheath.

[0084]FIG. 9d shows a perspective cut-away view of the sheath 4 with thevarious devices (i.e., the two grasping devices 108, the drive cable100, the actuating cable 450, and the endoscope 8) extending therethrough. Each of the various devices are further enclosed by one of aplurality of tubes 510 which allow either a rotational movement (for thecables 100, 450) or a longitudinal (for the two grasping devices 108 andthe endoscope 8) movement therein. Similar to the sheath 4, theplurality of tubes extend from a proximal end coupled to the controlhandle 6, to a distal end coupled to the working head assembly 2. Theplurality of tubes 510 provide protection against damage due to, forexample, abrasion, and provide an isolated path through the sheath 4which prevents tangling between the various devices.

[0085]FIG. 18 shows a cross-section of the control handle 6 which may beused in conjunction with a resectioning device of the invention. Thecontrol handle 6 may preferably be substantially “Y” shaped, with afirst branch 500 for operating the actuating mechanism 104 and a secondbranch 502 for operating the drive mechanism 102 and a body 520. Areceiving hole 512 runs longitudinally through the center of the body520 for receiving the endoscope 8 there through. A first forcetransferring mechanism 504 is coupled to an actuating control knob 508,and extends axially through the first branch 500, through the body 520,where it is coupled to the actuating cable 450 which extends through thesheath 4 to connect to the actuating mechanism 104. A second forcetransferring mechanism 506 is coupled to a drive control knob 510, andextends axially through the second branch 502, through the body 520,where it is coupled to the drive cable 100 which extends through thesheath 4 to the drive mechanism 102. Those skilled in the art willunderstand that the control handle may be designed in any variety ofshapes to accommodate, for example, different hand sizes, comfort, etc.In addition, different force transferring methods may also be usedinstead of a knob such as, for example, actuating levers, etc.

[0086] In operation, the user applies a rotational force to one of thecontrol knobs 508 and 510, the rotational force is transferred through arespective one of the force transferring mechanisms 504 and 506 whichthen transfers rotational force to a respective one of the drive cable100 and actuating cable 450, thereby operating the actuating mechanism104 or the drive mechanism 102 as described above.

[0087]FIG. 11 shows a device according to a second embodiment of thePresent invention in which like reference numerals identify the sameelements.

[0088] The anvil member 10 of this embodiment preferably has asubstantially circular or elliptical cross-section and is graduallytapered from the proximal face 14 to its distal end 16, forming abullet-like structure. This tapered shape allows the device to be moreeasily inserted into the patient's body as the distal end 16 has asmaller cross-sectional size than in the first embodiment. Those skilledin the art will understand that the anvil member 10 may have othertapered shapes besides a bullet-like structure without departing fromthe scope of the present invention.

[0089] Instead of providing the cut-out 13 shown in the first embodimentto receive the endoscope 8 therein, a substantially cylindrical firstendoscope lumen 13 extends axially through the center of the anvilmember 10. The distal end 16 of the anvil member 10 may preferably havea beveled edge 54 adjoining the first endoscope lumen 13 to allow for anexpanded field of forward vision via the endoscope 8.

[0090] The proximal housing 12 may preferably have a cross sectioncorresponding in size and shape to the cross section of the proximalface 14 of the anvil member 10 (i.e., substantially circular orelliptical). In this embodiment, the cavity 30 in the first embodimenthas been omitted and a substantially cylindrical second endoscope lumen52 extends axially through the center of the proximal housing 12.

[0091] However, as in the previous embodiment, two grasped holes 32, 33extend axially through the proximal housing. The two grasped holes 32and 33 may preferably be disposed between the mounting holes 26 a and 26b since the first endoscope lumen 13 now extends through the axialcenter of the proximal housing 12. In addition, the grasped holes 32, 33in this embodiment may preferably have a substantially circularcross-section. However, those skilled in the art will understand thatthe cross-sectional shape of the grasped holes 32 and 33 may be selectedto, for example, accommodate another type of device.

[0092] A receiving sleeve 55 is provided on the proximal end 12 b of theproximal housing 12 for receiving the endoscope 8 and for guiding theendoscope 8 into the proximal housing 12. The receiving sleeve 55 maypreferably have a first section 56 and a second section 58. The firstsection 56 and second section 58 may preferably both have an annularcross-section forming a continuous center hole 59 there through. Thecenter hole 59 has a diameter which preferably corresponds to thediameter of the receiving hole 52 BO that the endoscope 8 may becontinuously received through the center hole 59 into the secondendoscope lumen 52 in the proximal housing 12. The second section 58preferably has a thicker wall than the first section 56, such that anannular ring formed by the cross-section of the second sections 58 has alarger width than an annular ring formed by the cross-section of thefirst section 56.

[0093] In contrast to the endoscope lumen 40 disposed along theperiphery of the sheath 4 as shown in FIG. 1, the endoscope lumen 40 inthis embodiment preferably runs along an axial center of the sheath 4,so that when the sheath 4 is coupled to the working head assembly 2, asubstantially continuously aligned path is formed through the centerhole 59, through the second endoscope lumen 52, and through the firstendoscope lumen 13. The actuating shafts 400 and 105 and the drivecables 450 and 102 are then located concentric to the endoscope lumen 40in the sheath 4.

[0094]FIG. 12 shows a device according to a third embodiment of thepresent invention. The proximal face 14 of the anvil member 10 of thisembodiment has a cross section similar to the crescent-shapedcross-section of the anvil member 10 of the device of FIG. 1. Thus, theanvil member 10 has two horns 22 a and 22 b formed on either side of acut-out 13 which extends axially through the anvil member 10 from theproximal face 14 to the distal end 15 to receive the endoscope 8therein. As with the device of FIG. 11, the cross-sectional size of theanvil member 10 diminishes in overall size from a maximum at theproximal face 14 to a minimum size at the distal end 15, and the horns22 a and 22 b become less pronounced from the proximal face 14 to thedistal end 15. In a side view, the anvil member 10 becomes graduallytapered from the proximal end 14 to the distal end 16.

[0095] As in the device of FIG. 11, the tapered shape of the anvilmember 10 of the device of FIG. 12 allows for easier insertion of thedevice into the patient's body. In contrast to the second embodiment,the cut-out 13 provides a larger field of vision via the endoscope 8 asthe anvil member does not totally enclose the cut-out 13. And, as in thefirst embodiment, two substantially cylindrical mounting shafts 20 a and20 b are coupled to the proximal face 14 of the anvil member 10 on horns22 a and 22 b and are received within the mounting holes 26 a and 26 b,respectively.

[0096] In contrast to the previous embodiments, the proximal housing 12in this embodiment may preferably have a substantially ovalcross-sectional shape. This shape of the proximal housing 12 is formedby extending the proximal housing 12 shown in FIG. 1 around the cutout29 to create the substantially cylindrical second endoscope lumen 52.The oval shape allows the second endoscope lumen 52 to be offset fromthe axial center of the proximal housing 12 and aligned with the firstendoscope lumen 13. This offset of the second lumen 52 allows the cavity30 to be provided adjoining the blade slit 36. In all other materialrespects, the proximal housing 12 in this embodiment is substantiallyidentical to the proximal housing 12 illustrated in FIG. 1.

[0097]FIG. 13 shows a device according to a fourth embodiment of thepresent invention. This embodiment is substantially similar to theembodiment shown in FIG. 12. However, the proximal face 14 of the anvilmember 10 in this embodiment has a substantially oval-shaped crosssection corresponding to the proximal housing 12. The anvil member 10 istapered towards the distal end 16 to form a substantially bullet-likestructure having an oval-shaped cross-section. The cut-out 13 shown inFIG. 12 may preferably be enclosed within the anvil member 10 andthereby forms an extension of the first endoscope lumen 13.

[0098] A substantially semicircular shield 31 extends from the proximalface 14 of the anvil member 10 and shields a hemispherical portion ofthe gap formed between the anvil member 10 and the proximal housing 12.The shield 31 allows a tissue section to be drawn primarily in the gapbetween the staple-forming grooves 19 and the staple slits 34 withminimal spillover into the rest of the gap.

[0099] A recessed groove 35 may preferably be formed around a portion ofthe proximal housing 12 for slidably receiving the shield 31 therein.The recessed groove 35 may preferably have a size and shapesubstantially corresponding to the size and shape of the shield 31 sothat when the anvil member 10 is in its proximal most position, theshield 31 is received within the recessed groove 35 to form asubstantially completely continuous outer surface of the proximalhousing 12.

[0100] In operation, the user may utilize suction through the endoscope8 to draw a tissue section into the gap between the anvil member 10 andthe proximal housing 12. In such a situation, the shield 31 prevents aportion of the tissue section or loose debris from being pulled into thearea around the mounting shafts 20 a and 20 b which may otherwiseinterfere with the axial movement of the mounting shafts 20 a, 20 b. Inaddition, the shield 31 also serves to direct the pulling force of thesuction to pull tissue primarily in the gap between the staple forminggrooves 19 and the staple slits 34.

[0101]FIGS. 14a and 14 b show a device according to a fifth embodimentof the present invention in which the working head assembly 2 is coupledto the endoscope 8 without the sheath 4. As described above, distal ends500 a of control cables 500 (i.e., drive cable 100 and actuating cable450) may preferably be coupled to the working head assembly 2 whileproximal ends 500 b of the control cables 500 are coupled to the controlhandle 6 as in the previous embodiments. However, instead of using aflexible sheath 4 to receive the control cables 500 and the endoscope 8,the control cables 500 are inserted into respective tubes 510. Each ofthe tubes 510 should have a sufficient cross-section to allow thecontrol cables 500 to rotate within the tubes 510. The tubes 510 arethen fastened at various predetermined points along their lengths to theendoscope 8 by a plurality of fasteners 502. Those skilled in the artwill understand that many different types of fasteners may be usedeither alone or in combination for this purpose so long as the fastenersdo not impede the steering of the endoscope 8 or the rotation of thecables 500. Those skilled in the art will understand that tape (e.g.,surgical, electrical, etc.), electrical cable, rubber bands, otherbelt-style fasteners, etc. may be used as fasteners.

[0102] FIGS. 16-18 illustrate alternative configurations of the bladehousing 74 b and it will be understood that similar alternativeembodiments may be implemented for the blade housing 74 a.

[0103] The blade slit 36 continues through the blade housing 74 b intohousing portion 84 b which extends from a forward end at which the bladeslit 36 enters the blade housing 74 b to a rearward end where the bladeslit 36 and the housing portion 84 b terminate. A shield receiving slit480 extends through the blade housing 74 b substantially perpendicularto the housing portion 84 b between the forward and rearward endsthereof.

[0104] After an organ section has been stapled between the anvil member10 and the proximal housing 12, and the blade 202 is drawn through thestapled tissue, there may be a problem if tissue stretches along withthe blade 202 into the housing portion 84 b without being completelysevered. Withdrawal of the resectioned tissue might then lead to tearingof the tissue which is to remain in place.

[0105] As seen in FIG. 17, a flexible breakaway shield 482 having ashape and size substantially corresponding to the shape and size of theshield receiving slit 480 is inserted into the shield receiving slit480. After entering the housing portion 84 b, the cutting blade 202contacts the shield 482 and further progress of the blade 202 deformsthe shield 482 until the shield 482 is cut in half. When the shield 482is cut in half, each half snaps back pulling the tissue in a directionopposite the direction of travel of the blade allowing the cutting blade202 to completely sever the tissue.

[0106]FIG. 18 shows a second alternative arrangement in which a flexiblegate 484, having a first gate half 484 a and a second gate half 484 b,may be removably or fixedly mounted within the shield receiving slit480. Each of the halves 484 a and 484 b may preferably be mounted withina respective half of the shield receiving slit 480, so that a small gapformed there between substantially corresponds in width to the width ofthe cutting blade 202. The wiping action in a direction opposed to thedirection of travel of the blade 202 is substantially the same as thatof the shield 482 without requiring the severing and replacement of theshield 482 after each use.

[0107]FIGS. 19a and 19 b show a third alternative arrangement in which apair of tissue blockers 600 and 602 facilitate the cutting of theresectioned tissue. Although, the following discussion will focus on thefirst tissue blocker 600, those skilled in the art will understand thata similar arrangement may be provided on the second tissue blocker 602.

[0108] As shown in FIG. 19a, the first tissue blocker 600 is composed ofa first rectangular bar 610 and a second rectangular bar 612 situated ata first end 21 a of the guiding slit 21. The first rectangular bar 610has a first base 610 a and the second rectangular bar 612 has a secondbase 612 a, which are both fixedly coupled to the proximal face 14 ofthe anvil member 10 and arranged so that the bases 610 a, 612 b straddleboth sides of the guiding slit 21 with a gap formed there betweencorresponding to the width of the guiding slit 21.

[0109] A first slot 614 a is provided in the first base 610 a of thefirst rectangular bar 610, and a second slot 614 b is provided in thesecond base 612 a of the second rectangular bar 612 so that when therectangular bars 610, 612 are coupled to the anvil member 10, theflexible breakaway shield 482 (shown in FIG. 17) may be disposed withinthe slots 614 a, 614 b. As shown in FIG. 19c, a pair of L-shaped holes620, 622 are provided on both ends of the blade slit 30 on the distalend 12 a of the proximal housing 12. The L-shaped holes 620, 622 extendlongitudinally within the proximal housing 12 to receive the rectangularbars 610, 612 therein when the anvil member 10 is coupled to theproximal housing 12.

[0110] This arrangement operates similarly to the arrangement shown inFIG. 17, so that the wiping action of the shield 482 in a directionopposite to a movement of the blade 202 allows the blade 202 tocompletely cut through the resectioned tissue. Although the shield 482is initially a single piece in a first operation of the device, theshield 482 may be re-used without replacement in further operations withminimal diminishment of its effectiveness.

[0111]FIG. 20 shows a device according to a sixth embodiment of thepresent invention in which like reference numerals identify the sameelements. The sheath 4 is substantially more rigid and shorter than inprevious embodiments. Although this decreases the effective operativerange of the device, the rigidity of the sheath 4 increases its overallstructural strength, allowing greater forces to be transferred therethrough to the working head assembly 2 than in the previous embodiments.The cables 100, 450 driving the various mechanisms 102, 104 may thenneed to be stronger and stiffer in order to accommodate the increasedforces. As a result of these changes, the overall size of the workinghead assembly 2 may then be increased to, for example, treat lesionsthat may be too large for the devices according to the previousembodiments to treat in a single procedure.

[0112] FIGS. 21-25 show a device according to a seventh embodiment ofthe present invention in which the working head assembly 2 comprises theanvil member 10, a stapler member 17, and a connecting adapter 25. Asshown in FIG. 21, the anvil member 10 and the stapler member 17preferably have substantially semi-circular shapes complementary to oneanother such that, when they are positioned adjacent to each other, theyform a substantially annular clamp-like device (as shown in FIG. 23).The anvil member 10 and the stapler member 17 are pivotally connectedvia a substantially cylindrical hinge-pin 60 which is provided on adistal end 25 a of the connecting adapter 25. A proximal end 25 b of theconnecting adapter 25 may preferably be coupled to the sheath 4 in amanner similar to that in which the proximal housing 12 is connected tothe sheath 4 in the previous embodiments. Those skilled in the art willunderstand that the shape of the anvil member 10 and the stapler member17 may be modified to accommodate specific needs or applications withoutdeparting from the scope of the present invention.

[0113] As shown in FIG. 22, a plurality of first ring-like extensions 10b are formed on a first end 10 a of the anvil member 10. The firstextensions 10 b may preferably be separated a predetermined distancefrom one another to form a plurality of spaces in which a correspondingplurality of second ring-like extensions 17 b formed on a first end 17 aof the stapler member 17 are accommodated. The first extensions 10 b maysubstantially correspond in shape and size to the second ring-likeextensions 17 b so that when the first anvil end 10 a and the firststapler end 17 a are engaged, an alternating arrangement of first andsecond extensions 10 b, 17 b is formed in which the holes of each of thefirst and second extensions 10 b, 17 b are substantially aligned to forma continuous hole in which a hinge-pin 60 is received. Thus, thehinge-pin 60 and the first and second extensions 10 b, 17 b form a hingewhich allows the anvil member 10 and the stapler member 17 to pivotabout the hinge-pin 60. A locking ring 62 may preferably be attached toa distal end 61 of the hinge-pin 60 to secure the first and secondextensions 10 b, 17 b to the hinge-pin 60.

[0114] A first anchoring joint 23 a is formed on an interior face 10 iof the anvil member 10. The first anchoring joint 23 a may preferablyhave a substantially triangular cross-section viewed along thelongitudinal axis of the working head assembly 2. However, a side of thefirst anchoring joint 23 a that is attached to the anvil member 10 maypreferably be convex in shape complementary to the concave shape of theinterior face 10 i of the anvil member 10. A substantially similarsecond anchoring joint 23 b is formed on an interior face 17 i of thestapler member 17 having a size and shape corresponding to the size andshape of the anchoring joint 23 a.

[0115] As shown in FIG. 23, first and second coupling elements 64 a, 64b are disposed on respective anchoring joints 23 a, 23 b to couple theanchoring joints 23 a, 23 b to two rod links 150 a, 150 b, respectively.The rod links 150 a, 150 b provide a rigid coupling between theanchoring joints 23 a, 23 b and a distal end 154 of a push rod 152.Thus, a longitudinal force in a distal or proximal direction applied tothe push rod 152 is transferred to the anchoring joints 23 a, 23 b, andthereby to the anvil member 10 and the stapler member 17.

[0116] In operation, when a distally directed pushing force is appliedto the push rod 152, the force is transferred through the link rods 150a, 150 b to the anvil member 10 and the stapler member 17 via therespective anchoring joints 23 a, 23 b, gradually separating an anvilhead 10 c on the anvil member 10 from a stapler head 17 c on the staplermember 17 until they reach a tissue receiving position. Similarly, whena proximally directed pulling force is applied to the push rod 152, theanvil head 10 c and the stapler head 17 c are drawn toward one anotheruntil they reach a stapling position, in which the anvil head 10 c andthe stapler head 17 c are adjacent to one another separated by a narrowgap. As the anvil head 10 c and the staler bead 17 c are drawn togetherby the push rod 152, a stabilizer tongue 308 extending from the staplerhead 17 c of the stapler member 17 is gradually received within astabilizing groove 304 on the anvil head 10 c. This tongue/groovearrangement provides a guide and a securing/stabilization mechanism forthe anvil member 10 and the stapling member 17.

[0117] The anvil head 10 c is disposed on a second end 10 e of the anvilmember 10 that is opposite to the first end 10 a thereof. The anvil head10 c may preferably have a substantially rectangular cross-sectionlarger than a cross-sectional size of the rest of the anvil member 10.The anvil head 10 c has an anvil face 10 d on which a plurality ofstaple-forming grooves 19 may preferably be arranged in two offset,substantially straight lines. In addition, a substantially straightguiding slit 21 may preferably extend substantially along the center ofthe anvil face 10 d, substantially parallel to the lines ofstaple-forming grooves 19, while the stabilizing groove 304 ispreferably formed along a distal side of the anvil face 10 d forreceiving the stabilizer tongue 308. The stabilizing groove 304 maypreferably have a shape and size substantially corresponding to thestabilizing tongue 308 so that the stabilizing tongue 308 is snuglyreceived within the stabilizing groove 304 when the anvil member 10 andthe stapler member 17 are in the stapling position.

[0118] As shown in FIG. 23a, the stapler head 17 c is formed on a secondend 17 e of the stapler member 17 opposite to the first end 17 athereof, and preferably has a cross section corresponding, at least inthe area adjacent to a stapler face 17 d, to the size and shape of theanvil head 10 c. A plurality of staple slits 34 are arranged on thestapler face 17 d in positions corresponding to the position of thestaple-forming grooves 19 on the anvil head 10 c so that when thestapler face 17 d and anvil face 10 d are positioned adjacent to eachother, each of the plurality of staple slits 34 is substantially alignedwith a corresponding one of the plurality of staple forming groove 19.Additionally, a substantially straight blade slit 36 extends across thestapler face 17 d corresponding to the guiding slit 21 on the anvil head10 c so that when the stapler head 17 c and the anvil head 10 c arepositioned adjacent to one another, the blade slit 36 is substantiallyaligned with the guiding slit 21.

[0119] As shown in FIG. 23, the distal end 25 a of the connectingadapter 25 preferably has a cross-section corresponding to the shape andsize of the peripheral surface of the annular clamp-like shape formed bythe anvil member 10 and the stapler member 17 so that a substantiallysmooth, continuous outer surface is formed by the anvil member 10, thestapler member 17, and the connecting adapter 25 when the anvil member10 and the stapler member 17 are in the stapling position. Theconnecting adapter 25 is preferably gradually tapered from the distalend 25 a to the proximal end 25 b thereof, and the proximal end 25 b maythen be coupled to the sheath 4 as shown in FIG. 24. As further shown inFIG. 24, a substantially cylindrical endoscope lumen 52 preferablyextends axially through the center of the connecting adapter 25 forreceiving a conventional endoscope 8 there through. The connectingadapter 25 may also have a substantially cylindrical rod hole 322extending axially along the periphery of the connecting adapter 25extending through an area adjacent to the hinge-pin 60, for receivingthe push rod 152 therein.

[0120] As shown in the cut-away view of FIG. 25, a track 350 is providedwithin the stapler head 17 c extending within the stapler head 17 c froman area adjacent to a distal end 352 of the stapler head 17 c to an areaadjacent to a proximal end 354 thereof. FIG. 26 shows a cutaway view ofthe stapler head 17 c showing the track 350 having a substantiallyL-shaped cross-section. The track 350 may preferably be situated so thata first leg 350 a of the track 350 extends substantially beneath theplurality of staple slits 34 on the staple face 17 d, and a second leg350 b of the track 350 extends substantially beneath the blade slit 21on the staple face 17 d.

[0121] In a first configuration shown in FIG. 25, a wedgesled 402 isprovided (instead of the wedge 402 described in the previousembodiments) on a distal end 350 a of the track 350. The wedge-sled 402has a cut-out in a comer forming a cam surface 412 thereon and a bladehandle 408. This provides the wedge-sled 402 with a substantiallyL-shaped cross-section substantially corresponding to thecross-sectional shape of the track 350. The wedge-sled 402 is arrangedin the track 350 so that the cam surface 412 is substantially disposedin the first leg 350 a of the track facing toward the plurality ofstaple slits 34. Furthermore, the wedge-sled 402 is arranged in thetrack 350 so that the blade handle 408 is substantially disposed in thesecond leg 350 b beneath the blade slit 21. Thus, when the cutting blade202 is coupled to the blade handle 408, the cutting blade 202 extendsout of the blade slit 21 as in the previous embodiments. As shown inFIG. 26, the stabilizing tongue 308 has a receiving slit 309 forreceiving the cutting blade 202 therein when the wedgesled 402 ispositioned at the distal end 350 a of the track 350. This preventsunintentional cutting of tissue as the device is inserted and guidedwithin the organ.

[0122] As shown in FIG. 25, an actuating cable 450 for operating thestapler head 17 c is coupled to the leading edge 402 d of the wedge-sled402 and extends through the track 350, through a tube 332 (which iscoupled to the proximal end 354 of the stapler head 17 c and extendsthrough the sheath 4 to the control handle) of the plurality of tubes510 (shown in FIG. 9d), and is then coupled to the control handle 6 (notshown).

[0123] In operation, the wedge-sled 402 is initially positioned at thedistal end 350 a of the track 350 with the blade 202 received within thereceiving slit 309 of the stabilizing tongue 308 as the operatormaneuvers the device to a desired location within the body. While thedevice is being maneuvered to the desired location, the anvil member 10and the stapler member 17 are located adjacent to each other in thestapling position. When the desired position is reached, the operatorpushes the push rod 152 distally to separate the anvil member 10 and thestapler member 17 into the tissue receiving position. Then the operatordraws the portion of tissue to be resectioned into the gap between thestapler member 17 and the anvil member 10 and draws the push rod 152proximally to return the anvil member 10 and the stapler member 17 tothe stapling position, gripping the tissue to be resected within thegap. The operator then pulls actuating cable 459 proximally, drawing thewedge-sled 402 towards the proximal end 350 b of the track 350. As thecam surface 412 on the wedge-Bled passes beneath each one of theplurality of staple slits 34, the cam surface 412 drives each one of aplurality of staple drivers 472 (each being disposed within acorresponding one of the staple slits 34) sequentially driving aplurality of staples out of the staple slits 34 to staple the tissuegripped between the anvil head 10 c and the stapler head 17 c. Inaddition, the cutting blade 202 coupled to the blade handle 408 of thewedge-sled 402 is pulled through the blade slit 21 to resection thetissue which has now been stapled off from the organ.

[0124] When the tissue has been resectioned, the operator pushes theoperating cable 450 distally to return the cutting blade 202 to thereceiving slit 309 of the stabilizing wedge 308. The device may then bewithdrawn from the body.

[0125] As shown in FIGS. 23 and 25, the anvil member 10 and the staplermember 17 have a tissue receiving position shown in FIG. 25, and astapling position shown in FIG. 23. Therefore, it is necessary to allowthe actuating cable 450 disposed within the tube 332 and received withinthe stapler head 17 c to correspondingly move with the stapler member17. Accordingly, a channel 330 is provided in the connecting adapter 25to receive the tube 332 therein. The channel 330 may preferably beformed within the connecting adapter 25 to substantially correspond tothe arc path along which the tube 332 is pulled by the stapler member17, as the stapler member 17 moves between the tissue receiving and thestapling positions. Thus, the channel minimizes bending and crimping ofthe tube 332.

[0126] Those skilled in the art will understand that although theproximal housing 12 in any of the embodiments may preferably be composedof a metallic-type material, the proximal housing 12 may also becomposed of a clear plastic-type material which would allow the user tooperate the working head assembly 2 under visual observation bypartially withdrawing the endoscope 8 into the second endoscope lumen 52in the proximal housing 12. The user could then look through the wallsof the endoscope lumen 52 into the proximal housing 12 to, for example,observe whether each of the plurality of staple drivers 472 have beenactuated. In addition, the user may also observe whether the wedge 402shown in FIGS. 10a and 10 b is locked into the blade portion 420 asdescribed above. Alternatively, selected portions of the proximalhousing 12 may be composed of the clear plastic-type material providinga “window” to view through the proximal housing 12.

[0127] Those skilled in the art will also understand that although theabove-described embodiments show mechanical force transmission betweenthe control handle and the working head assembly, this device couldalternatively include an electronic control for receiving input from anoperator coupled to a series of motors in the working head assembly.Those skilled in the art will further understand that the relativepositioning of the stapling mechanisms and the position adjustingmechanisms to each other may be reversed, placing the staplingmechanisms in a distal-most position in relation to the positionadjusting mechanism.

[0128] In a different embodiment, the FTRD according to the presentinvention includes a removable integrated surgical staple retainer thatsecures the staples during shipping and can be used to gauge theoutermost diameter of an endoscope. The integrated surgical stapleretainer is preferably mounted between the proximal housing 12 and theanvil member 10 of the FTRD when in position to retain the staples.

[0129] In one embodiment, shown in FIG. 27, the integrated surgicalstaple retainer 623 can have a calibrating portion 624 and a retainingportion 626. The calibrating portion 624 defines a circular opening 625having a diameter substantially equal to a diameter of the workingchannel formed in the head assembly 2 of the full thickness resectioningdevice 628. The retaining portion 626 can have positioning elements thatinclude protrusions such as ridges 627, which can be hollow, and whichhold the integrated surgical staple retainer 623 in position relative tothe head assembly 2. In one exemplary embodiment, the integratedsurgical staple retainer 623 is placed between the proximal housing 12and the anvil member 10, which are then moved near one another. Theridges 627 protrude behind the edge of anvil member 10, preventingremoval of the integrated surgical staple retainer 623. In analternative embodiment, the retaining portion 626 can include a groove,a flat surface, or any other feature to mechanically keep the integratedsurgical staple retainer 623 in place, instead of a plurality of hollowridges.

[0130] The calibrating portion 624 can be located adjacent to, to eitherside of, in front, or behind the retaining portion 626 as long as thecalibrating portion does not interfere with the retaining function. Inone embodiment of the present invention, the calibrating portion 624 canbe inside the arc of the retaining portion 626. As seen in FIG. 28, inanother embodiment, the retaining portion 626 can be to the side of thecalibrating portion 624. The integrated surgical staple retainer 623 canalso have a grasping portion 630 which can be located adjacent to, toeither side of, in front, or behind the retaining or calibratingportion. As seen in FIG. 28, in one embodiment, the grasping portion 630is adjacent to the retaining portion 626 of the integrated surgicalstaple retainer opposite to the calibrating portion 624. An advantage ofthis particular embodiment is that the FTRD 628 does not need to beopened in order to remove and expose the calibrating portion 624. Theretaining portion 626 remains in place while the circular opening 615 isslid over the length of an endoscope 8 to gauge the diameter of theendoscope. In this manner, the staples are less likely to fall out ofhousing 12 while the device is being handled.

[0131] As shown in the exemplary embodiment of FIG. 29, in relation tothe FTRD 628, the retaining portion 626 of the integrated surgicalstaple retainer 623 can be placed between the proximal housing 12 andthe anvil member 10 of the FTRD 628. In one embodiment, the integratedsurgical staple retainer 623 can be placed between the staple slits 34of the proximal housing 12 and the staple forming grooves 19 of theanvil member 10. The calibrating portion 624 can be placed inside acavity defined by head assembly 2. Alternatively, the calibratingportion 624 can extend outside of head assembly 2, or can be in anynon-interfering position.

[0132] As shown in FIG. 30, to use the retaining portion 626 of theintegrated surgical staple retainer 623, the distance 629 between theanvil member 10 and the proximal member 12 is minimized such that theplurality of ridges 627 of the retaining portion 626 fill the stapleforming grooves 19 of the anvil member 10. Alternatively, ridges 627 areretained in place by the circumference of anvil member 10. An undersidesurface 640 of integrated surgical staple retainer 623 thus fully coversthe staple slits 34 of the proximal housing 12. In an alternativeexemplary embodiment, a flat surface of the retaining portion 626contacts the staple forming grooves 19 and also covers the staple slits34. In that case, the integrated surgical staple retainer 623 can beheld in place by different shaped protrusions that engage the stapleforming grooves 19, or more generally, that engage the anvil member 10so that integrated surgical staple retainer 623 remains in positionrelative to the head assembly 2.

[0133]FIG. 31 shows the use of the calibrating portion 624 of theintegrated surgical staple retainer 623. The circular opening 625 isslid over the length of an endoscope 8 to ensure a maximum diameter 630never exceeds the diameter of opening 625. If the entire endoscope 8 isable to slide through the circular opening 625, this indicates that theendoscope will be able to slide through a working channel of the FTRD628.

[0134] The use of the integrated surgical staple retainer according tothe present invention includes, for example, the following steps. TheFTRD 628 is unpacked from its shipping package so that a user can holdthe grasping portion of the integrated surgical staple retainer 623 toremove it from between the proximal housing 12 and the anvil member 10of the FTRD. The user then slides the calibrating portion 624 of theintegrated surgical staple retainer along the length of an endoscope 8.If the endoscope 8 slides smoothly through the opening 625 of thecalibrating portion 624 of the integrated surgical staple retainer 623,the user has affirmative knowledge that the endoscope will be able toslide through the working channel of that FTRD 628 without binding, evenif the maximum diameter 630 is greater than a nominal diameter ofendoscope 8.

[0135] Although the present invention has been described with respect toseveral exemplary embodiments, those skilled in the art will understandthat there are many other variations of the above described embodimentswithin the teaching of the present invention, which is to be limitedonly be the claims appended hereto.

What is claimed is:
 1. An integrated surgical staple retainer of a FTRD,comprising: a calibrating portion defining a circular opening, thecircular opening having a diameter substantially equal to a diameter ofa working channel of the FTRD; and a retaining portion having a surfaceadapted to limit movement of the surgical staples held in the FTRD, theretaining portion being adjacent to the calibrating portion; and agrasping portion adjacent to the retaining portion.
 2. The integratedsurgical staple retainer according to claim 1, further comprising: apositioning element disposed on the retaining portion, the positioningelement holding the integrated surgical staple retainer in positionrelative to the FTRD.
 3. The integrated surgical staple retaineraccording to claim 1, wherein the positioning element comprises aplurality of protrusions.
 4. The integrated surgical staple retaineraccording to claim 1, wherein the calibrating portion is adapted to beplaced in a cavity formed by a head assembly of the FTRD.
 5. Theintegrated surgical staple retainer according to claim 1, wherein theretaining portion is adapted to be placed between a proximal housing andan anvil member of the FTRD.
 6. The integrated surgical staple retaineraccording to claim 5, wherein the retaining portion is adapted to beplaced between staple slits of a proximal housing of the FTRD and stapleforming grooves of an anvil member of the FTRD.
 7. The surgicalintegrated surgical staple retainer according to claim 1, wherein theretaining portion is adapted to immobilize the staples held in the FTRD.8. A method of gauging an outermost diameter of an endoscope for use inan FTRD comprising: removing an integrated surgical staple retainer frombetween an anvil member and a proximal housing of an FTRD to releasesurgical staples held in the proximal housing; sliding through acalibrating portion of the integrated surgical staple retainer anendoscope; and determining that a maximum diameter of the endoscope fitsthrough the calibrating portion.
 9. The method of gauging the outermostdiameter of an endoscope for use in an FTRD according to claim 8 furthercomprising the preliminary step of increasing a distance between theanvil member and the proximal housing.
 10. A method of retaining staplesin a FTRD comprising: placing a retaining portion of an integratedsurgical staple retainer between a proximal housing and an anvil memberof the FTRD; and minimizing the distance between the anvil member andthe proximal housing such that the retaining portion remains in positionrelative to a head assembly of the FTRD.
 11. The method of retainingstaples in a FTRD according to claim 10 further comprising; placing aretaining portion of the integrated surgical staple retainer betweenstaple slits of a proximal housing of the FTRD and staple forminggrooves of an anvil member of the FTRD, the retaining portion beingadjacent to a calibrating portion of the integrated surgical stapleretainer; and minimizing the distance between the anvil member and theproximal housing such that the retaining portion contacts the stapleforming grooves of the anvil member and covers the staple slits of theproximal housing.